Global Regulatory Writing Manager Job at Amgen (Tokyo)

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Manager Regulatory Affairs

Beam is seeking a Manager Regulatory Affairs to progress a broad portfolio of ad...

Location

United States , Cambridge

Salary:

125000.00 - 155000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS in a medical or scientific field required
Strong grasp of drug development lifecycle and strategy
A minimum of 8 years of experience working in Regulatory Affairs
Knowledge of US and global regulatory procedures and practices
Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP)
Experience supporting teams through interactions with Regulatory Agencies and Health Authorities
Ability to develop and maintain collaborative working relationships with internal and external partners
Excellent written/verbal communication skills, attention to detail, organizational skills

Job Responsibility

drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines
Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations
Maintain and update regulatory submission plans, timelines, and other core strategic documents
represent Regulatory Affairs on cross functional and project teams
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time

Fulltime

Pharmacovigilance and regulatory affairs manager BeNeLux

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities a...

Location

Netherlands , Utrecht

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
Knowledge of applicable laws and regulations to ensure full compliance
Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
Proficiency in speaking, comprehending, reading and writing Dutch is required
Proficiency in speaking, comprehending, reading and writing English is required
Ability to think strategically & execute tactically

Job Responsibility

Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
Collaborate with commercial, medical and market access to realize cross-functional objectives

What we offer

Competitive salary and benefits package
Opportunities for professional growth and development

Manager/Sr. Manager, Global Compliance and Training

The Manager/Sr. Manager, Compliance and Training, will provide expertise in trai...

Location

United States , Durham, NC

Salary:

125000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry
8+ years of relevant experience in a GMP and GXP environment with at least 3 years of demonstrated experience with the development, maintenance, and training oversight required
General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry
Skilled in determining the state and needs of the learner and defining the end goal of instruction
Excellent interpersonal effectiveness, written/verbal communication, influencing, and negotiation skills
Ability to work independently
Excellent computer skills and advanced knowledge of Quality Systems
Direct experience with Quality Management Systems, Document Management Systems, Learning Management Systems, and Microsoft Office, including Word and Excel
Veeva experience required
Self-motivator with the ability to follow up on and complete multiple projects simultaneously

Job Responsibility

Develops, leads, and implements training initiatives that are aligned with business strategies
Design, develop and deliver instructional materials, both digital and physical, in an efficient, effective, appealing, engaging way
Manages the performance/effectiveness of quality system training programs
Work collaboratively on the GXP integrated digital landscape to support, resolve system technical issues and communicate best practices for electronic quality training systems
Assist in the refinement of system user training and support training delivery
Assist in improving and maintaining Beam’s overall Quality Management System (QMS), including policies and procedures, while keeping them current with emerging and changing regulations
Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables
Contributes to the generation, review, and approval of computer system test scripts
Support site and function audit preparations with respect to system functionality
Support development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of Quality Systems

Fulltime

Global Trial Manager - Early Development

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , CARY, BLUE BELL, RAHWAY, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS/BSc or RN
At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
Strong clinical project management skills and experience in driving milestones
Excellent communication and interpersonal skills to effectively work with cross-functional teams
Proficient in trial management systems and MS Project (or equivalent PM software)
Knowledge of ICH/GCP and regulatory guidelines/directives

Job Responsibility

Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
Develops the strategic scenarios of designs for early phase clinical development plan
Ensures standard processes, tools, and procedures are used consistently
Routine engagement with Clinical Investigators
Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
Ongoing safety data review and completion of study data collection, data lock, and analysis
Resolution of cross-functional study-specific issues
Communication of study status to key stakeholder and updating relevant systems
Ensures study personnel are appropriately trained and understand study timelines and deliverables

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Banamex Governance Model Validation Group Manager

The Regulatory Risk Group Manager is accountable for management of complex/criti...

Location

Mexico , Ciudad De Mexico

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

10+ years relevant experience
Excellent proficiency in Microsoft Office – particularly Excel (metrics and data analysis), PowerPoint (presentation decks), and Word (writing and editing procedural and technical documentation)
Broad understanding of classifiable and delinquency managed credit and operational policies and procedures
Thorough knowledge of financial and risk reporting
Familiarity with regulatory landscape facing global banks
Previous experience in managing Regulatory Inspections and Audits within a financial services company
Project management knowledge and experience working with diverse group of stakeholders
Proven relationship management skills
Required Licensing/Registration: Series 4, Series 7, Series 9, Series 10, Series 24, Series 63, Series 65
Bachelor's/University degree, Master's degree preferred

Job Responsibility

Accountable for management of complex/critical/large professional disciplinary areas
Leads and directs a team of professionals
Responsible for providing risk strategic analytics, information management across Citibank products
Responsible for communicating to executive management implications of existing and opposed regulation
Regulatory risk project management ownership for delivery of regulatory solutions
Analyzes new risk-related guidelines, best practice standards, rules and regulations
Directs the approach to answering questions and involve appropriate Risk functions in Citi with audits and regulators
Project Management of various deliverables for Portfolio Risk Review chapter
Significant interaction with a wide range of senior bank and risk management colleagues, as well as external stakeholders
Identifies and sponsors the development opportunities for key individuals

Fulltime

Medical Writer

The healthcare industry requires that we abide by regulations from all around th...

Location

Malta , Marsa

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

BS or MS in scientific or clinical discipline with excellent writing skills
2 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory
Knowledge of computer software Microsoft Word and Adobe Acrobat products
Microsoft Project and Visio are a plus
Experience in scientific and/or medical writing
Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner
Strong organizational skills and meticulous attention to detail
Familiarity with clinical trial-related and regulatory clinical submission templates and documents
Apply global regulatory authority regulations and/or guidance
Manage multiple projects with competing priorities

Job Responsibility

Develops high quality clinical documents ensuring scientific excellence and regulatory compliance
Writing, interpreting and summarizing clinical and non-clinical data
Compiling information and ensuring delivery within timelines
Ensure compliance of clinical documents with Baxter procedures, national and international regulatory requirements and guidelines
Collaborate with cross-functional team members and serve as MW representative at study team meetings
Prepare document timelines, with guidance from manager
Develop knowledge of one or more Baxter therapeutic areas

Global Regulatory Writing Manager

Amgen

Location:
Japan , Tokyo

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 19, 2026

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